Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/25/2018 |
| Start Date: | April 2010 |
| End Date: | June 2013 |
Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Tavocept is an investigational drug that is being developed to see if it can increase the
survival of patients who are being treated with chemotherapy as well as to see if it can
prevent or reduce side effects of chemotherapy. This research study is aimed at trying to
find out if people with advanced adenocarcinoma of the lung who are treated with a standard
combination of chemotherapy drugs will live longer if they are also treated with an
investigational drug called "Tavocept." Another objective of this research study is to find
out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage,
anemia, and nausea and vomiting that can occur with these drug combinations. The drug
combinations that will be used in this research study will include either paclitaxel and
cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to
treat people with advanced NSCLC. Every patient on this research study will be treated with
standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these
will be recommended by your research study doctor), which will be given in combination with
cisplatin.
survival of patients who are being treated with chemotherapy as well as to see if it can
prevent or reduce side effects of chemotherapy. This research study is aimed at trying to
find out if people with advanced adenocarcinoma of the lung who are treated with a standard
combination of chemotherapy drugs will live longer if they are also treated with an
investigational drug called "Tavocept." Another objective of this research study is to find
out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage,
anemia, and nausea and vomiting that can occur with these drug combinations. The drug
combinations that will be used in this research study will include either paclitaxel and
cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to
treat people with advanced NSCLC. Every patient on this research study will be treated with
standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these
will be recommended by your research study doctor), which will be given in combination with
cisplatin.
Inclusion Criteria:
- Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma
(including bronchioalveolar cell carcinoma) of the lung
- No prior systemic treatment for non-small cell lung cancer including chemotherapy,
immunotherapy, hormonal therapy, targeted therapies or investigational drugs
Exclusion Criteria:
- Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg,
small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or
cytological diagnosis of primary lung cancer
- Adenocarcinoma arising from primary sites other than the lung
- Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging
System 7th edition)
- Patients with unstable CNS mets within 21 days before randomization
We found this trial at
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